ABSTRACT
Supplemented with a convenient keyword index, this book provides a pocket-sized verbatim reproduction of key US FDA regulations. It presents the requirements as set forth by the FDA CFR 21 Parts 807, 812, and 814 to sell or distribute medical devices, including the pre-market approval requirements for the devices. The easy-to-use format that puts t
21 CFR Part 807 Establishment Registration and Device Listing for Manufacturing and Initial Importers of Devices 21 CFR Part 812 Investigational Device Exemptions 21 CFR Part 814 Premarket Approval of Medical Devices PART 807—ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES Subpart A—General Provisions Sec. 807.3 Definitions. Subpart B—Procedures for Device Establishments; Subpart C—Registration Procedures for Foreign Device Establishments Subpart D—Exemptions Subpart E—Premarket Notification Procedures
